Separate Provision for Subsequent Importers of Approved Medical Devices

To simplify and expedite the import process for already-approved medical devices and IVDs, CDSCO has implemented a new provision. A circular dated 15.9.25, states that w.e.f 11.9.25 a separate provision for “Subsequent Importers” of already-approved medical devices and IVDs has been implemented. The aim is to streamline the regulatory process and reduce processing timelines for these already approved products. In this article, we will detail the latest notification on the separate provision for subsequent importers.

What is the separate provision for subsequent importers of medical devices?

As per a circular dated 15.9.25, a separate provision for subsequent importers is now live on the CDSCO online portal as of 11 September 2025. This update streamlines the regulatory process for entities wishing to import already-approved medical devices and IVDs under the Medical Devices Rules, 2017. This change is aimed at reducing processing timelines and separating brand approval from routine endorsement applications. This will make the regulatory process easy for multi-importer strategies and parallel distribution models. Key insights into the notification:

• Purpose: To simplify and expedite the import process for medical devices already approved by the Central Licensing Authority.
• New Workflow: Subsequent importers can now directly apply through a dedicated module in the online system.
• Checklist Provided: CDSCO has issued a specific checklist for these applications to ensure clarity and compliance.
• Tool Tips Available: The portal includes guidance notes to help applicants navigate technical requirements.

This provision is ideal for expanding distribution networks, enabling parallel import strategies, and reducing time-to-market for high-demand devices.

Eligibility criteria for availing the subsequent importer benefit

• You must be importing a device that has already received import license approval from the Central Licensing Authority (CLA).
• The manufacturer of the subsequent device should be same as that of the primary device.
• The device must be listed under the Medical Devices Rules, 2017.
• The device must already have a valid import license issued to the primary importer.
• The subsequent importer must have manufacturer authorization and meet QMS requirements.

Examples of devices that will become eligible for the separate provision for subsequent importers

The CDSCO’s separate provision for subsequent importers applies to medical devices and IVDs that have already been approved by the Central Licensing Authority (CLA) under the Medical Devices Rules, 2017. We have listed some devices that will become eligible for the subsequent import provision:

Category	Device Examples
Diagnostic Equipment	Digital thermometers, ECG machines, blood pressure monitors
Surgical Instruments	Laparoscopic tools, surgical staplers, electrosurgical units
Orthopedic Devices	Bone plates, screws, joint implants, spinal fixation systems
Dental Devices	Dental chairs, handpieces, impression materials
IVDs (In Vitro Diagnostics)	Glucose test strips, pregnancy test kits, ELISA kits, RT-PCR reagents
Wound Care Products	Hydrocolloid dressings, negative pressure wound therapy systems
Hospital Furniture	ICU beds, overbed tables, patient stretchers
Respiratory Devices	Nebulizers, CPAP machines, oxygen concentrators
Ophthalmic Devices	Phacoemulsification systems, intraocular lenses
Rehabilitation Aids	Wheelchairs, walking aids, prosthetic limbs

9 Key requirements for subsequent importer application

1. Reference to existing import license: You must cite the import license number of the primary importer already approved by the Central Licensing Authority (CLA).
2. Authorization from Manufacturer: A fresh authorization letter from the overseas manufacturer has to be mandatorily obtained. The name of the subsequent importer has to be specifically mentioned in this letter.
3. Product Details: Information on the product should include the brand name, device category/classification, intended use, and packaging and labeling artwork.
4. Quality Management System (QMS) Certificate: A valid ISO 13485:2016 certificate or an equivalent QMS documentation is a necessary requirement for import license application.
5. Undertaking of Compliance: A signed declaration confirming adherence to the Medical Devices Rules, 2017 will be required.
6. Technical Documentation: A detailed technical documentation supporting the application will be required. It should include instructions for use (IFU), product brochure, and risk analysis summary (if applicable)
7. Checklist Compliance: CDSCO has issued a dedicated checklist for the subsequent importer application pathway. Notably, each item in the checklist must be addressed to avoid rejection.
8. Separate Application per Device: Each medical device will require its own submission, even if multiple devices are covered under the primary license.
9. Portal Submission: Applications must be submitted via the CDSCO online portal under the new “subsequent importer” module.

Separate provision for subsequent importers: Application process

1. Login to CDSCO Portal: Access the CDSCO online system with your credentials and login to the online portal.
2. Select “Subsequent Importer” Module: A new tab distinct from the standard Form MD-14/MD-15 route has been added. This tab is specifically for the subsequent importer provision.
3. Fill in Application Details: Mention the existing import license number of the primary importer. Provide product details, brand name, and intended use. Upload technical documentation, such as IFU, labels, packaging artwork, to support the application.
4. Attach Required Documents: Authorization letter from the overseas manufacturer has to be provided. Also, a valid QMS certificate (e.g., ISO 13485) is required. Moreover, an undertaking stating compliance with MDR-2017 will be required.
5. Use the Provided Checklist: CDSCO has published a dedicated checklist to ensure completeness of the application. Notably, it includes everything from format requirements to naming conventions. Refer to the checklist to correctly file your application.
6. Submit and Track: Submit the application and monitor the status via the portal dashboard. Tooltips and guidance notes have been provided to assist with navigation.

Processing time of the application

Processing time of the subsequent importer application is expected to be shorter than the standard import license application’s time, as the product is already approved. By introducing this provision, the CDSCO aims to reduce redundancy and accelerate market access for compliant devices.

Possible reasons for rejection of application

We have presented some possible reasons that could lead to the rejection of application. Understanding these pitfalls will help avoid application rejection. Based on the latest CDSCO guidance and portal updates, we have presented the possible reasons for rejection of subsequent importer applications:

• Incorrect Reference to Primary Import License: Failing to cite the correct and active import license number of the primary importer or referencing an expired/suspended license will lead to application rejection.
• Missing or Invalid Authorization Letter: If the overseas manufacturer does not issue a fresh, device-specific authorization naming the subsequent importer, the application will be rejected outright.
• Incomplete Technical Documentation: Missing Instructions for Use (IFU), product brochure, or risk summary will be another reason for rejection. Also, poor formatting or non-compliance with CDSCO’s checklist structure can lead to application rejection.
• Labeling Non-Compliance: Artwork that does not align with MDR-2017 requirements can also lead to rejection. Missing importer name, license number, or shelf-life details are some of the non-compliance issues.
• Invalid or Expired QMS Certificate: ISO 13485 certificate that has expired or has been issued by a non-accredited body is going to lead to outright rejection.
• Failure to Use the Correct Portal Module: Submitting under the standard MD-14/MD-15 route instead of the dedicated “Subsequent Importer” tab.
• Lack of Undertaking: Absence of signed declaration of compliance with Medical Devices Rules, 2017 can be a major reason.
• Multiple Devices in One Application: It is important to apply for each device separately, even if covered under the same primary license.
• Document Mismatch: Discrepancies between product details in the authorization letter and technical documents (e.g., model number, brand name) will lead to subsequent importer application rejection.

This latest CDSCO update on the separate provision for subsequent importers can be confusing to handle. Our team of experts will be more than happy to guide you. Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us guide you through the latest regulatory updates.